TERMINATED

Understanding the Pathophysiology of Migraine Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Migraine is the most common headache disorder, prevalent in 18% of females and 6% of males. Emergency room visits, physician consults, hospitalizations, medications, and indirect costs such as lost work days and decreased productivity place the global economic burden of migraines at over 20 billion dollars. It is prevalent in 28 million people in the US alone. Symptoms include unilateral, throbbing, debilitating headache pain accompanied by nausea, vomiting, photophobia, and phonophobia. Upwards of 75% of migraine patients have reduced functionability, have lost time at work, and 1/3 of patients require bed rest to manage the symptoms. The health-related impact on quality of life was comparable with that experienced by patients with congestive heart failure, hypertension, or diabetes. While the burden of migraines on our society is clear, the pathophysiology of migraines remains largely unknown. The trigeminovascular system, including the external and internal carotid arteries and their associated sensory fibers which subserve the head have long been implicated in the pain and cutaneous allodynia experienced by migraine patients. Wolff in 1953, was the first to posit that migraine headache pain is the caused by dilation or circumferential expansion of the extracranial carotid artery. He demonstrated that migraineurs had twice the pulse amplitude in their external carotid arteries compared to control subjects and these changes were directly correlated to migraine symptoms. In a 2008 study, randomized migraineurs received nitroglycerin via peripheral IV or placebo for 20 minutes prior to obtaining magnetic resonance angiography (MRA). Nitroglycerin, a potent dilator of blood vessels, reliably induced migraine-like pain in up to 80% of patients, and transient dilation of vessels of up to nearly 40%, mostly in the extracranial vessels. Sumatriptan's efficacy in migraine relief provides further evidence for this theory, as it is a selective extracranial vessel constrictor which does not cross the blood brain barrier. The goal of this current work is to utilize the direct, real-time angiography, which provides a high resolution map of vasculature, and demonstrate changes in vessel flow in patients who have migraine headache attacks. This information may guide therapeutic interventions in the future in order to better treat these migraine patients.

Official Title

Understanding the Role of the External Carotid Artery in the Pathophysiology of Migraine Pain

Quick Facts

Study Start:2017-01
Study Completion:2025-04-24
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT03026101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * No changes to neurological exam within the preceding 6 months
  2. * Requirement of a diagnostic cerebral angiogram for a previously treated aneurysm or arteriovenous malformation with no history of persistent disease
  3. * A documented diagnosis of migraine made by a neurologist
  4. * Migraines that are refractory to standard migraine pharmacologic treatment, with or without aura, either prophylactic or abortive, with persistent severe, debilitating symptoms
  5. * Experience migraine symptoms at least twice a month
  6. * Migraines symptomology which is discernible from other non-migraine headache pain
  7. * Subjects must sign a consent form for both angiography and for participation in this study, and must be willing to undergo angiography for the evaluation of their symptoms
  1. * Patients with persistent intracranial vascular anomalies, such as aneurysms, which remain untreated, in whole or in part
  2. * Patients taking vasoactive drugs including epinephrine, norepinephrine, dopamine, dobutamine, isoprenaline, dopexamine, milrinone, amrinon, levosimendan, glucagon, phenylephrine, metaraminol, ephedrine, vasopressin, digoxin, and levothyroxine
  3. * Patients with underlying cardiac pathology including but not limited to coronary artery disease, heart attacks, or severe atherosclerosis
  4. * Patients taking medications such as phosphodiesterase 5 (PDE5) inhibitors or other nitroglycerin analogues
  5. * Patients with pulmonary disease requiring supplemental oxygen therapy
  6. * Patients with contraindications to nitroglycerin or calcium channel blocker use
  7. * Patients who have had coffee, tea, or alcohol in the 12 hours before the start of the angiogram
  8. * Patients having other headache conditions, pain syndromes, or prior intracranial therapies or craniotomies for management of any vascular lesions that would require angiography for surveillance and confound their evaluation of their migraine pain
  9. * Patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as:
  10. * Severe vessel tortuosity or stenosis
  11. * Vasospasm not responsive to medical therapy
  12. * Abnormal communication between intracranial and extracranial vessels either in the past or during the study procedure
  13. * Patients who are not able to reliably report symptoms
  14. * Patients without the capacity to consent
  15. * Patients who do not consent to participate
  16. * Patients who are pregnant
  17. * Children

Contacts and Locations

Principal Investigator

David J Altschul, MD
PRINCIPAL_INVESTIGATOR
Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center
Bronx, New York, 10467
United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

  • David J Altschul, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-01
Study Completion Date2025-04-24

Study Record Updates

Study Start Date2017-01
Study Completion Date2025-04-24

Terms related to this study

Additional Relevant MeSH Terms

  • Migraine Disorders
  • Migraine, Classic
  • Migraine Without Aura